RP2 + Tivozanib for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for kidney cancer that has spread and worsened despite previous treatments. It uses a modified herpes virus, RP2, to target and kill cancer cells while activating the immune system. This is combined with tivozanib, a drug that stops cancer growth and prevents new blood vessels from forming. Ideal participants have kidney cancer that has worsened after one or two rounds of prior treatment, including both immunotherapy and a specific type of cancer drug. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic anticancer therapies within 4 weeks of the first dose of the study drug, and certain conditions require that anticoagulant therapies be safely stopped during the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RP2, a modified herpes simplex virus designed to target tumor cells, was tested in earlier studies. In these studies, most patients experienced severe or life-threatening side effects, but researchers considered the overall safety manageable. This indicates that while side effects were common, they were generally expected and could be managed with proper care.
Tivozanib, in contrast, has undergone more extensive study and is already approved for treating kidney cancer. Its side effects are well-documented and usually manageable. Tivozanib works by blocking proteins that help tumors grow and spread.
Both treatments have been used in people before. While side effects can occur, they are generally known and can be managed by doctors. Prospective trial participants should discuss possible side effects with their doctor to understand how they might be affected.12345Why are researchers excited about this trial's treatments?
Researchers are excited about RP2 combined with tivozanib for kidney cancer because it offers a unique approach that differs from typical treatments like surgery, radiation, and targeted therapies such as sunitinib and pazopanib. RP2 is a modified virus designed to selectively target and destroy cancer cells when injected directly into tumors, providing a novel mechanism of action. Meanwhile, tivozanib is an oral medication that blocks signals promoting blood vessel growth in tumors, potentially enhancing the anti-cancer effects. This combination aims to effectively attack the cancer from within while cutting off its blood supply, offering hope for improved outcomes in kidney cancer management.
What evidence suggests that RP2 and tivozanib could be effective for metastatic renal cell cancer?
Research shows that RP2, a modified herpes simplex virus, targets and destroys cancer cells in kidney cancer while aiding the immune system in fighting these cells. Early studies suggest it can shrink tumors and boost the immune response. Tivozanib has delayed the progression of cancer in patients with advanced kidney cancer, with some studies reporting a delay of up to 11.9 months. In this trial, participants will receive a combination of RP2 and tivozanib, which might be a strong approach, as it directly attacks the tumor and cuts off its blood supply.13678
Who Is on the Research Team?
Charles B Nguyen
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with metastatic renal cell cancer that has worsened after immunotherapy. Participants must have previously been treated with immune checkpoint inhibitors and now show disease progression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RP2 intratumorally and tivozanib orally. RP2 is administered on days 1, 15, 29, 43, 64, 85, 106, and 127, with treatment repeating every 2 weeks for the first 4 doses and then every 3 weeks for subsequent doses. Tivozanib is taken orally once daily on days 1-21 of each 28-day cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes CT scans, urine and blood sample collection, and possibly tumor biopsies.
What Are the Treatments Tested in This Trial?
Interventions
- RP2
- Tivozanib
Trial Overview
The trial tests RP2, a modified virus targeting tumor cells and boosting the immune response, alongside tivozanib, which inhibits proteins to stop tumor growth and new blood vessel formation. This combination aims to treat advanced kidney cancer post-immunotherapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive RP2 intratumorally on days 1, 15, 29, 43, 64, 85, 106, and 127. Treatment repeats every 2 weeks for the first 4 doses and then every 3 weeks for subsequent doses for up to 8 doses in the absence of disease progression or unacceptable toxicity. After completion of the first course of treatment, patients who meet criteria may receive another course of RP2 intratumorally every 3 weeks for up to an additional 8 doses. Patients also receive tivozanib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and urine and blood sample collection throughout the study. Additionally, patients may undergo tumor biopsies throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
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Preliminary safety and efficacy results from an open-label
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Intratumoral heterogeneity in kidney cancer - PMC
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Kidney Cancer Highlights from ASCO 2025
The researchers reported a manageable and consistent safety profile although most patients – 96% – did experience severe or life-threatening ...
Safety outcomes and immunological correlates in a ...
Here, we report the first prospective, non-comparative clinical trial to evaluate the feasibility, clinical benefits, and immunologic changes of combining three ...
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